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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K161650
Device Name Polysmith Sleep System, Model NTI7593
Applicant
Neurotronics, Inc.
3600 NW 43rd Street, STE F1
Gainesville,  FL  32606
Applicant Contact David Pezet
Correspondent
Neurotronics, Inc.
3600 NW 43rd Street, STE F1
Gainesville,  FL  32606
Correspondent Contact David Pezet
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
DQA   MLO   OLZ  
Date Received06/15/2016
Decision Date 01/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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